Hemostasis valves and methods of use

ABSTRACT

Devices, systems, and methods for sealing medical devices, particularly during intravascular access, are disclosed herein. Some aspects relate to a hemostatic valve for sealing a wide range of medical devices, such as catheters, wires, embolectomy systems. The valve can include an elongate member having a first end, a second end, and a central lumen extending therebetween. A reinforcement structure extends along at least a portion of the elongate member and is coupled to the elongate member. A shell defining a first aperture and a second aperture may be included, which first and second apertures can be fluidly coupled by the elongate member. A tensioning mechanism is coupled to the shell and to the elongate member, the tensioning mechanism can be moveable between a first configuration wherein the tensioning mechanism is collapsed and the central lumen is sealed and a second configuration wherein the central lumen is open.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/117,519, filed on Aug. 30, 2018, and titled “HEMOSTASIS VALVES ANDMETHODS OF USE,” which claims the benefit of U.S. Provisional PatentApplication No. 62/554,931, filed on Sep. 6, 2017, and titled“HEMOSTASIS VALVES AND METHODS OF USE,” each of which is hereinincorporated by reference in its entirety.

BACKGROUND

During a surgical procedure, a portion of a patient's body (e.g.,vasculature) is accessed to allow for performance of a desiredintervention or treatment. During such surgical procedures, it isdesired to minimize patient blood loss, prevent delivery of air into thevasculature, and to maintain the sterility of the accessed portions orsites of the patient's body so as to prevent issues such as infection.Further, the desire for improved patient outcomes has led to thedevelopment of hemostasis valves that facilitate minimally invasivesurgery.

In minimally invasive surgery, small incisions are created through ablood vessel which one or several catheters are inserted. Each of theseone or several catheters can define a lumen extending longitudinallythrough that catheter. These catheters are moved to a position proximateto tissue, nerves, or other body structures targeted by the surgery, andthen tools for performing the procedure are inserted through the lumensof some or all of these catheters.

To minimize blood loss, prevent delivery of air into the vasculature,and to facilitate maintenance of sterility within the patient's body(e.g., blood vessel), these catheters are equipped with hemostasisvalves. These valves seal or selectably seal the lumens of thecatheters. In many instances, these valves can seal the lumen of thecatheter when a tool extends through the catheter, and specificallythrough the valve. Additionally the valves can seal the lumen when atool is removed or does not extend through the catheter.

While such traditional hemostasis valves are greatly beneficial forintravascular access, they have some drawbacks. For example, some valvesmay not seal adequately for all interventional applications or tools,and/or the operation of some valves may be complicated for operator use.The drawbacks of such valve designs may in turn increase the complexityof any surgery performed therewith and/or reduce patient safety (e.g.,bleeding, infection, and/or other detrimental complications).Accordingly, new and improved hemostasis valves and methods of use aredesired.

SUMMARY

The following relates to valves, medical systems incorporating valves,and methods of using the same. The valve can include a tubular memberthat can be constricted, collapsed, and/or sealed by one or severaltensioning mechanisms. The tensioning mechanism can include at least onefilament that extends around at least a portion of the tubular member.The filament can interact with the tubular member to constrict,collapse, and/or seal the tubular member via manipulation of thetensioning mechanism(s). A tool can be inserted through the valve togain access to a patient's body and specifically to gain access to ablood vessel. Through the use of the tensioning mechanism and filamentto constrict, collapse, and/or seal the tubular member, the valve canseal around a wide range of tool sizes and shapes, as well as multipletools of differing sizes simultaneously. Additionally, such a valvecreates a robust seal that maintains its seal when a vacuum is appliedsuch as occurs during aspiration.

Aspects of the present disclosure relate to a hemostatic valve forsealing a medical device. The hemostatic valve includes an elongatemember having a first end, a second end, and a central lumen extendingtherebetween. In some embodiments, the elongate member is pliable. Thehemostatic valve can include a reinforcement structure extending alongat least a portion of the elongate member, such that the reinforcementstructure is coupled to the elongate member. The hemostatic valveincludes an active tensioning mechanism coupled to the elongate member.In some embodiments, the tensioning mechanism is moveable between afirst configuration in which the central lumen is constricted and sealedand a second configuration in which the central lumen is open.Optionally, the valve may be manually adjusted by the user tointermediate positions between fully open and fully closed.Additionally, an instrument (e.g. catheter) may provide an intermediateposition where the valve creates hemostasis without user adjustment.

In some embodiments, the elongate member can be a compliant polymertube. In some embodiments, the tensioning mechanism can include at leastone filament extending at least partially around the elongate member. Insome embodiments, the reinforcement structure is positioned between theat least one filament and the elongate member. In some embodiments, thereinforcement structure can be a braided mesh. In some embodiments, thereinforcement structure is coupled to the elongate member at a positionproximate to the first end of the elongate member and at a positionproximate to the second end of the elongate member. In some embodiments,the reinforcement structure is not coupled to the elongate member at aposition between the first end of the elongate member and the second endof the elongate member. In some embodiments, the central portion of thecompliant polymer tube that is constrained or collapsed by thetensioning mechanism, and at least one filament, is not coupled to thereinforcement structure.

In some embodiments, the tensioning mechanism can include an actuatorcoupled to the at least one filament. In some embodiments there are twotensioning mechanisms coupled to the at least one filament that operatein opposite directions. In some embodiments the two tensioningmechanisms are attached to the same filament. In some embodiments thetwo tensioning mechanisms are attached to opposing filaments. In someembodiments, the actuator can be moveable to control movement of the atleast one filament from a first position in which the central lumen isconstricted and sealed to a second position in which the central lumenis open. In some embodiments, the at least one filament is in the firstposition when the tensioning mechanism is in the first configuration. Insome embodiments, the actuator is biased towards the first position. Insome embodiments, the actuator is biased toward the second position. Insome embodiments, the actuator can be a manual actuator.

In some embodiments, the at least one filament forms a loop around theelongate member. In some embodiments, the at least one filament forms abight around a portion of the elongate member. In some embodiments, theat least one filament can include a first filament and a secondfilament. In some embodiments, each of the first filament and the secondfilament are coupled to the same actuator. In some embodiments, each ofthe first filament and the second filament are coupled to differentactuators. In some embodiments, the first filament and the secondfilament are moveable from the first position to the second position. Insome embodiments, each of the first filament and the second filamentform a loop around the elongate member. In some embodiments, the firstfilament forms a first bight around a first portion of the elongatemember, and the second filament forms a second bight around a secondportion of the elongate member. In some embodiments, the first bightextends through the second bight.

In some embodiments, the hemostatic valve can include a shell defining afirst aperture and a second aperture. In some embodiments, the elongatemember extends from the first aperture to the second aperture andfluidly couples the first aperture and the second aperture. In someembodiments, the tensioning mechanism is self-adjustable to seal aroundtools of different sizes extending through the hemostatic valve. In someembodiments, the central lumen can comprise a single lumen, and in someembodiments, the central lumen can comprise a plurality of lumens.

One aspect of the present disclosure relates to a delivery system forintravascular access of a blood vessel within a patient's body. Thedelivery system includes a catheter having a first end, a second end,and a catheter lumen extending therebetween and a hemostatic valvecoupled to the first end of the catheter. The hemostatic valve includesa tubular member having a first end, a second end, and a central lumenextending therebetween. In some embodiments, the central lumen of thetubular member is fluidly coupled with the catheter lumen. Thehemostatic valve includes an active tensioning mechanism coupled to thetubular member, the tensioning mechanism can be moveable between a firstconfiguration in which the tensioning mechanism constricts on thecentral lumen and the central lumen is sealed and a second configurationin which the central lumen is open.

In some embodiments, the hemostatic valve further includes areinforcement structure extending along at least a portion of thetubular member. In some embodiments, the reinforcement structure islocated between the tensioning mechanism and the tubular member. In someembodiments, the reinforcement structure can be a braided mesh. In someembodiments, the reinforcement structure is coupled to the tubularmember at a position proximate to the first end of the tubular memberand at a position proximate to the second end of the tubular member. Insome embodiments, the reinforcement structure is adhered to the tubularmember at the first end of the tubular member and at the second end ofthe tubular member. In some embodiments, the reinforcement structure isuncoupled to the tubular member between the first end of the tubularmember and the second end of the tubular member.

In some embodiments, the tensioning mechanism can include at least onefilament extending at least partially around the tubular member. In someembodiments, the tensioning mechanism can include an actuator coupled tothe at least one filament. In some embodiments, moving the tensioningmechanism from the first configuration to the second configuration caninclude moving the actuator and the thereto coupled at least onefilament from a first position to a second position. In someembodiments, the filament constricts and seals the central lumen of thetubular member when the filament is in the first position.

In some embodiments, the actuator can be a manual actuator. In someembodiments, the actuator can include a pair of opposing and depressablebuttons, which buttons can be biased towards an undepressed position. Insome embodiments, the central lumen is sealed when the buttons are inthe undepressed position. In some embodiments, the filament can be amonofilament. In some embodiments, the filament can be at least one of:a polymer filament; or a metallic filament. In some embodiments, thecatheter can include a thrombus extraction device.

One aspect of the present disclosure relates to a method of sealing adelivery device accessing a blood vessel of a patient. The methodincludes inserting the delivery device including a catheter and ahemostatic valve into the blood vessel of the patient. In someembodiments, the catheter can have a first end, a second end, and acatheter lumen extending therethrough. In some embodiments, thehemostatic valve can be coupled to the first end and can have a tubularmember defining a central lumen fluidly coupled with the catheter lumenand a tensioning mechanism coupled with the tubular member. In someembodiments, the tensioning mechanism collapses and seals the centrallumen in a first configuration and thereby seals access to the bloodvessel. The method can include moving the tensioning mechanism of thehemostatic valve to a second configuration. In some embodiments, thecentral lumen is open and access to the blood vessel is unsealed whenthe tensioning mechanism is in the second configuration. The method caninclude advancing a shaft of a tool through the delivery device until afirst end of the tool reaches a desired position within the blood vesselof the patient and a portion of the shaft is positioned within thecentral lumen of the tubular member. The method can include returningthe tensioning mechanism of the hemostatic valve to the firstconfiguration such that the tubular member collapses on the shaft of thetool and seals around the shaft of the tool.

In some embodiments, the method includes retracting the shaft of thetool from the delivery device. In some embodiments, the tensioningmechanism is maintained in the first configuration during and after theretracting of the shaft of the tool from the delivery device. In someembodiments, the tensioning mechanism is moved to the secondconfiguration during the retracting of the shaft of the tool from thedelivery device, and the tensioning mechanism is returned to the firstconfiguration after the shaft of the tool is retracted from the deliverydevice.

In some embodiments, the tensioning mechanism can include at least onefilament extending at least partially around the tubular member. In someembodiments, the at least one filament collapses the tubular member whenthe tensioning mechanism is in the first configuration. In someembodiments, the at least one filament circumferentially constricts thetubular member to collapse the tubular member when the tensioningmechanism is in the first configuration. In some embodiments, thehemostatic valve can include a reinforcement structure located betweenthe at least one filament and the tubular member.

In some embodiments, the at least one filament forms a loop around theelongate member, and moving the tensioning mechanism from the secondconfiguration to the first configuration reduces a size of the loop tothereby constrict the tubular member within the loop. In someembodiments, the filament forms at least one bight around a portion ofthe elongate member. In some embodiments, the filament can include afirst filament and a second filament. In some embodiments, the at leastone bight can include a first bight oriented in a first direction andformed by the first filament and a second bight oriented in a seconddirection and formed by the second filament. In some embodiments, thefirst and second bights overlap to encircle a portion of the tubularmember within a constricting area.

In some embodiments, moving the tensioning mechanism from the secondconfiguration to the first configuration can include moving the firstbight in the first direction and the second bight in the direction toreduce the size of the constricting area and collapse and seal thecentral lumen of the tubular member. In some embodiments, the tensioningmechanism can include an actuator. In some embodiments, moving thetensioning mechanism to the second configuration can includemanipulating the actuator. In some embodiments, the method includesapplying a vacuum to the delivery device and/or delivery system toaspirate material through the catheter. In some embodiments, the centrallumen remains sealed during the aspiration. In some embodiments, thetool can include a thrombus extraction device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of a delivery device.

FIG. 2 is a side-section view of one embodiment of a hemostasis valve ina first configuration.

FIG. 3 is a side-section view of one embodiment of the valve in a secondconfiguration.

FIG. 4 is a side-section view of one embodiment of the valve in thefirst configuration and with a tool extending through the valve.

FIG. 5 is a side-section view of one embodiment of a single-buttonhemostasis valve in a first configuration.

FIG. 6 is a perspective view of a filament of a valve forming a loop.

FIG. 7 is a perspective view of two filaments of a valve, each of thefilaments forming a loop.

FIG. 8 is a perspective view of two overlapping and interlocked bightsin an open configuration.

FIG. 9 is a perspective view of two overlapping and interlocked bightsin a closed configuration.

FIG. 10 is a flowchart illustrating one embodiment of a method forsealing a valve and/or catheter.

FIG. 11 is a side view of one embodiment of a thrombectomy systemincluding the delivery device.

FIG. 12 is a side-section view of another embodiment of a hemostasisvalve having two-piece caps.

DETAILED DESCRIPTION

The present disclosure relates to a valve that can be used a hemostasisvalve. This valve, also referred to herein as a garrote valve can sealwith or without a tool extending through the valve. The garrote valveprovides convenient, single-handed operation for a wide range of medicaldevices including catheters, wires, embolectomy systems, or the like.This single-handed operation of the garrote valve allows the user toeasily and quickly swap different tools being used through the valvewithout compromising hemostasis and therefore simplifying the procedure.Combined with single-handed operation, the garrote valve provides robustsealing either with or without a tool extending through the valve. Thisrobust sealing minimizes leakage in applications with a pressuredifferential on different sides of the valve. This pressure differentialcan arise, for example, during the application of vacuum aspiration in aprocedure. Even under such conditions, as well as under otherconditions, the garrote valve maintains seal integrity and preventsleakage in one or both directions.

The garrote valve includes a tubular member. The tubular member is aflexible member that defines a central lumen, which can, in someembodiments, define a single lumen, and in some embodiments, defines aplurality of lumens. In some embodiments, each of the plurality oflumens can comprise the same size and shape, and in some embodiments,some or all of the plurality of lumens can comprise different sizes andshapes. In some embodiments, for example, the plurality of lumens cancomprise a lumen sized and/or shaped to receive a guide wire and a lumensized and/or shaped to receive a tool. The tubular member extends atleast partially through a constricting mechanism. The constrictingmechanism can be moved from a first configuration to a secondconfiguration, and the constricting mechanism can collapse and/or sealthe central lumen of the tubular member when the constricting mechanismis in the first configuration. The constricting mechanism creates theabove-discussed robust seal of the tubular member and thus of the valve.

With reference now to FIG. 1 , a perspective view of one embodiment of adelivery system 100, also referred to herein as a delivery device 100,is shown. The delivery system 100 can include a catheter 102 and agarrote valve 104, also referred to herein as valve 104. The catheter102 can comprise a shaft 106, also referred to herein as an elongatesheath 106, having a proximal end 108, also referred to herein as afirst end 108, that can connect to the valve 104 and a distal end 110,also referred to herein as a second end 110. The shaft 106 can define acatheter lumen 112 extending from the proximal end 108 of the shaft 106to the distal end 110 of the shaft 106. The catheter 102 andspecifically the shaft 106 can comprise a variety of shapes and sizesand can be made from a variety of materials. In some embodiments, thecatheter 102 can be flexible and/or can be made from a biocompatiblematerial. The elongate sheath 106 can have an outer diameter of at least4 French, at least 6 French, at least 8 French, at least 10 French, atleast 12 French, at least 14 French, at least 18 French, at least 20French, at least 22 French, between 4 French and 30 French, between 8French and 24 French, between 12 French and 20 French, and/or any otheror intermediate size.

The valve 104 can include an outer shell 114. The outer shell 114 cancomprise a variety of shapes and sizes and can be made from a variety ofmaterials. In some embodiments, the outer shell 114 can be made from oneor several polymers or composites. The outer shell 114 can includefeatures that allow interaction with and/or control of the valve 104 tomove the valve 104 between the first configuration and the secondconfiguration.

The outer shell 114 can include a proximal cap 116 located at a proximalend 118 of the outer shell 114 and a distal cap 120 located at a distalend 122 of the shell 114. The proximal cap 116 can include and/or housea proximal aperture 124, also referred to herein as a proximal channel124, a first channel 124, or a first aperture 124, that extends throughthe proximal cap 116, and the distal cap 120 can include and/or house adistal aperture 126, also referred to herein as a distal channel 126, asecond channel 126, or second aperture 126, that extends through thedistal cap 120. As seen in FIG. 1 , the distal cap 120 connects to theshaft 106 of the catheter 102 at the distal end 122 of the valve 104.

The proximal cap 116 and the distal cap 120 are connected via a housing128. The housing 128 can be a one-piece housing 128 or a multi-piecehousing 128. In the embodiment depicted in FIG. 1 , the housingcomprises a two-piece housing 128. The housing 128 can be configured toreceive and couple with each of the proximal cap 116 and the distal cap120, and as seen in FIG. 1 , the housing 128 is coupled with each of theproximal cap 116 and the distal cap 120 to secure the relative positionof the proximal cap 116 and the distal cap 120 with respect to eachother.

The housing 128 can define an interior channel 130 through which anelongate member 132, also referred to herein as a tubular member 132, aseptum 132, or a tubular septum 132, can extend and connect the proximalcap 116 and the distal cap 120. The elongate member 132 can comprise avariety of shapes and sizes and can be made from a variety of materials.In some embodiments, the elongate member 132 can comprise a complianttubular structure that can be, for example, a thin-walled complianttubular structure. The thin-walled structure of the elongate member 132can facilitate the collapse, and specifically the uniform collapse ofthe elongate member 132 and the sealing of the elongate member 132. Insome embodiments, the elongate member 132 is an elastic, resilientmaterial that may comprise a polymer including either a natural orsynthetic polymer. In some embodiments, the elongate member can comprisean elastic, resilient material that may comprise silicone, urethane,ethylene-vinyl acetate, natural or synthetic rubber or other elastomersknown in the art. In some embodiments, the elongate member 132 cancomprise a silicone tube.

The elongate member 132 can comprise a proximal end 134, also referredto herein as a first end 134, that can couple to the proximal cap 116,and a distal end 136, also referred to herein as a second end 136, thatcan couple to the distal cap 120. The elongate member 132 can define acentral lumen 138 that can extend from the first end 134 to the secondend 136 of the elongate member 132. The elongate member 132 can becoupled to the proximal cap 116 such that the central lumen 138 isfluidly coupled with the proximal aperture 124 of the proximal cap 116,and the elongate member 132 can be coupled to the distal cap 120 suchthat the central lumen 138, as seen in FIG. 2 and in FIG. 3 , is fluidlycoupled with the distal aperture 126 of the distal cap 120.

The central lumen 138 of the elongate member 132 can be defined by awall of the elongate member 132 that can have a thickness that isuniform along the length of the elongate member 132 between the firstend 134 and the second end 136, or that is non-uniform along the lengthof the elongate member 132 between the first end 134 and the second end136. In some embodiments, the wall can have a thickness that isapproximately between 0.005 inches and 0.05 inches, and/or approximatelybetween 0.010 inches and 0.030 inches. As used anywhere herein,“approximately” refers to a range of +/−10% of the value and/or range ofvalues for which “approximately” is used.

In some embodiments, the elongate member 132 can be cylindricallyshaped, and specifically can be circular-cylindrically shaped. In someembodiments, the elongate member 132 can be dog-bone shaped tofacilitate, for example, connection to each of the proximal cap 116 andthe distal cap 120. In some embodiments, the elongate member 132 caninclude one or several outward-extending protuberances that engage withall or portions of a constricting mechanism 141, also referred to hereinas a tensioning mechanism 141, of the valve 104 to secure a position ofall or portions of the constricting mechanism 141 with respect to theelongate member 132. In some embodiments, the constricting mechanism 141can be self-adjusting to seal around tools of different sizes extendingthrough the valve 104.

The constricting mechanism 141 can, in some embodiments, collapse andseal the elongate member 132 via compression and/or constriction, andspecifically via constriction with at least one filament 150. Theconstricting mechanism 141 can comprise: an actuator 142 which can be amanual actuator such as one or several buttons 144; and the at least onefilament 150 that can extend at least partially around the elongatemember 132. In some embodiments, the use of the constricting mechanism141 can facilitate sealing of the valve around tools or instruments of awide range of sizes and/or diameters, and particularly around tools orinstruments that fit through the elongate member 132.

The housing 128 can further include one or several retention features140. The one or several retention features 140 of the housing can engagewith and retain all or portions of the constricting mechanism 141 of thevalve 104. In some embodiments, the one or several retention features140 of the housing 128 can retain the actuator 142 and/or can couple theactuator 142 to the housing 128. The actuator 142 can comprise anydesired type of actuator including, for example, a manual actuatorand/or an automated actuator such as, for example, an electromechanicalactuator including a solenoid-based actuator. In some embodiments, theactuator can comprise one or several buttons 144, and specifically, asdepicted in FIG. 1 , the actuator 142 can comprise a first button 144-Aand a second button 144-B. Alternatively, and as depicted in FIG. 5 ,the actuator 142 can comprise a single button 144. In such anembodiment, the filament 150 can be coupled to the single button 144 andto a portion of the housing 128 such as, for example, to grip portion500 of the housing 128 such that the movement of the single button 144causes the sealing and/or opening of the elongate member 132 and of thevalve 104.

The actuator 142 can be biased towards a configuration such as, forexample, biased towards the first configuration or biased towards thesecond configuration. As depicted in FIG. 2 , which shows theconstricting mechanism 141 in the first configuration, the actuator 142can be biased towards the first configuration wherein the elongatemember 132 is collapsed and/or sealed by a bias feature 146. In thisfirst configuration, the buttons 144 can be in a first position, alsoreferred to herein as an undepressed position. This bias feature 146can, as shown in FIG. 2 , include a first spring 148-A configured tobias the first button 144-A towards the first position corresponding tothe first configuration of the constricting mechanism 141, and a secondspring 148-B configured to bias the second button 144-B towards a firstposition corresponding to the first configuration of the constrictingmechanism 141. One or both of the first spring 148-A and the secondspring 148-B can comprise a tension spring, compression spring, atorsion spring, a coil spring, or any other desired type of spring.

In some embodiments, one or both of the first spring 148-A and thesecond spring 148-B can generate sufficient force so as to allowactuation of the actuator 142 with a single hand and so as to collapseand seal the elongate member 132 when the constricting mechanism 141 isin the first configuration. In some embodiments, one or both of thefirst spring 148-A and the second spring 148-B can generate a force of:at least 0.1 pounds, at least 0.2 pounds, at least 0.3 pounds, at least0.4 pounds, at least 0.5 pounds, at least 0.6 pounds, at least 0.7pounds, at least 0.8 pounds, at least 0.9 pounds, at least 1 pound, atleast 1.5 pounds, at least 2 pounds, at least 3 pounds, at least 5pounds, and/or at least 10 pounds and in some embodiments one or both ofthe first spring 148-A and the second spring 148-B can generate a forceapproximately between: 0.1 and 10 pounds, 0.1 and 5 pounds, 0.1 and 1.5pounds, 0.2 and 1 pounds, and/or 0.4 and 0.8 pounds.

The constricting mechanism 141 can include at least one filament 150that extends at least partially around the elongate member 132. In someembodiments, the at least one filament 150 can circumferentiallyconstrict the elongate member 132 to collapse and seal the elongatemember 132 when the constricting mechanism 141 is in the firstconfiguration. The filament can be made from a variety of materialsincluding, for example, a polymer, a synthetic, and/or a metal. In someembodiments, the filament 150 can be nylon, stainless steel, nitinol,silicone, or the like. In some embodiments, the filament can comprise asingle strand such as, for example, a monofilament, and in someembodiments, the filament can comprise a plurality of strands that canbe, for example, twisted, woven, grouped, and/or fused to form thefilament. In some embodiments, the filament 150 can comprise one orseveral threads, lines, cords, rope, ribbon, flat wire, sheet, or tape.

The filament 150 can be coupled to the actuator 142 such that thefilament 150 selectively constricts, collapses, and/or seals theelongate member 132, and specifically the central lumen 138 of theelongate member 132 based on the movement and/or position of theactuator 142. In some embodiments, the filament 150 can be connected toone or both of the buttons 144-A, 144-B such that the filament 150collapses, constricts, and/or seals the elongate member 132 andspecifically the central lumen 138 of the elongate member 132 when thebuttons 144-A, 144-B are in the first position, and the filament 150 canbe connected to one or both of the buttons 144-A, 144-B such that theelongate member 132 and specifically the central lumen 138 of theelongate member 132 is open and uncollapsed when the buttons 144-A,144-B are in the second position. In some embodiments in which theactuator 142 comprises a single button 144, as depicted in FIG. 5 , thefilament 150 can be connected to the button 144 and to the housing 128such that the filament 150 is tightened when the button 144 moves to thefirst position.

In some embodiments, the at least one filament 150 can extend along anaxis 152 that can be perpendicular to a central axis 154 of the elongatemember 132 and/or of the apertures 124, 126. In some embodiments, theaxis 152 of the at least one filament 150 can intersect and beperpendicular to the central axis 154 of the elongate member 132 and/orof the apertures 124, 126. In some embodiments, the actuator 142, andspecifically the buttons 144-A, 144-B can move along this axis 152 whenmoved from the first position to the second position.

In FIG. 3 , an embodiment of the valve 104 with the constrictingmechanism 141 in the second configuration is shown. As specificallyshown, both of the first and second buttons 144-A, 144-B are in thesecond position, depressed into the retention features 140 of thehousing 128. In this second position, the filament 150 is loosened,thereby allowing the expansion of the elongate member 132 and theunsealing of the central lumen 138 of the elongate member 132.

As further seen in FIG. 3 , the proximal cap 116 has a proximal end 300and a distal end 302. The proximal cap 116 can include a funnel portion301 of the proximal aperture 124, which funnel portion 301 canfacilitate insertion of a tool into the proximal aperture 124. Thedistal end 302 of the proximal cap 116 can partially extend into theinterior channel 130 of the housing 128. The proximal cap 116 caninclude a mating feature 304 that can mate with the proximal end 134 ofthe elongate member 132. In some embodiments, the proximal end 134 ofthe elongate member 132 can fit over the mating feature 304 of theproximal cap 116. The proximal end 134 of the elongate member 132 can becompressed between the mating feature 304 of the elongate member 132 anda portion of the interior channel 130 of the housing 128 into which themating feature 304 is inserted to thereby secure the proximal end 134 ofthe elongate member 132 on the mating feature 304. In some embodiments,the proximal end 134 of the elongate member 132 can be further securedon the mating feature 304 by a proximal O-ring 306 that can becompressed between the housing 128 and the mating feature 304 of theproximal cap 116 to sealingly couple the elongate member 132 to theproximal cap 116.

The distal cap 120 has a proximal end 308 and a distal end 310. Thedistal cap can include a mating feature 312 located on the proximal end308 of the distal cap 120, which mating feature 312 can mate with thedistal end 136 of the elongate member 132. In some embodiments, thedistal end 136 of the elongate member 132 can fit over the matingfeature 312 of the distal cap 123. The distal end 136 of the elongatemember 132 can be compressed between the mating feature 312 of theelongate member 132 and a portion of the interior channel 130 of thehousing 128 into which the mating feature 312 is inserted to therebysecure the distal end 136 of the elongate member 132 on the matingfeature 312. In some embodiments, the distal end 136 of the elongatemember 132 can be further secured on the mating feature 312 by a distalO-ring 314 that can be compressed between the housing 128 and the matingfeature 312 of the proximal cap 116 to sealingly couple the elongatemember 132 to the distal cap 120.

The distal cap 120 can, in some embodiments, further include a side portbarb 314 that can extend laterally away from the distal cap 120 andspecifically away from the distal aperture 126 of the distal cap 120.The side port barb 314 can define a side port channel 316 that canextend through the side port barb 314 and fluidly connect to the distalaperture 126. In some embodiments, the side port barb 314 can include asecurement feature 318 such as a barb that can secure coupling of a hoseor tube to the side port barb 314.

In some embodiments, the side barb 314 can be used to apply a vacuum tothe portions of the delivery device 100, and particularly to portions ofthe delivery device 100 that are distal of the axis 152 along which theelongate member 132 seals. This vacuum can be applied to aspirate amaterial through the delivery device 100, and specifically through thecatheter 102 of the delivery device. This aspirated material can be abiological material including, for example, bodily fluids, multi-phasebodily materials that can include, for example, a fluidic portion and atleast one solid portion, or the like.

In some embodiments, due to the narrowing shape of the elongate member132 when the constricting mechanism 141 is in the first configuration, avacuum applied to the portions of the delivery device 100 distal to theaxis 152 draws the elongate member 132 towards the first configurationand can, in some embodiments, increase the strength, robustness, and/orstrength of the seal of the valve 104. This attribute of the valve 104can provide benefits over other valve designs in which a vacuum cancompromise the seal of the valve, and thus the ability to draw a vacuumand aspirate can be limited.

In some embodiments, the valve 104 can further include a reinforcementstructure 320 that can extend along all or portions of the elongatemember 132. The reinforcement structure 320 can facilitate the uniformcollapse of the elongate member 132, can prevent the at least onefilament 150 from cutting through and/or tearing the elongate member132, and can assist in guiding one or several tools through the elongatemember 132. The reinforcement structure 320 can be tubular, can extendalong and around the elongate member 132, and can be positioned so as tobe between the elongate member 132 and the at least one filament 150.

The reinforcement structure 320 can include a proximal end 322 and adistal end 324. In some embodiments, the reinforcement structure 320extends along and around the elongate member 132, and is positioned suchthat the proximal end 322 of the reinforcement structure 320 isproximate to the first end 134 of the elongate member 132 and the distalend 324 of the reinforcement structure 320 is proximate to the secondend 136 of the elongate member 132.

The reinforcement structure 320 can be coupled to the elongate member132. In some embodiments, the reinforcement structure 320 is coupled tothe elongate member 132 along the length of the reinforcement structure320, and in some embodiments, the reinforcement structure 320 is coupledto the elongate member 132 and distinct positions along the length ofthe elongate member 132 and/or the reinforcement structure 320. In oneembodiment, for example, the reinforcement structure 320 can be coupledto the elongate member 132 at one or both of the proximal end 322 of thereinforcement structure 320 and the distal end 324 of the reinforcementstructure 320 and/or at one or both of the first end 134 and the secondend 136 of the elongate member 132. In some embodiments, thereinforcement structure 320 can be coupled to the elongate member 132via one or several other components of the valve 104. In someembodiments, the reinforcement structure 320 can be coupled to theelongate member 132 via the compression of the reinforcement structure320 and the elongate member 132 between the housing 128 and one or bothof the proximal 116 and the distal 120.

In some embodiments, the reinforcement structure 320 can be adhered tothe elongate member 132 via, for example, an adhesive such as siliconeadhesive. In some embodiments, the adhesive can be circumferentiallyapplied to the reinforcement structure 320 and/or the elongate member132 in an adhesive ring that can, for example, a have a lengthapproximately between: 0.010 inches and 0.5 inches; 0.02 and 0.4 inches;0.050 inches and 0.0250 inches, or any other or intermediate range.

In one embodiment, each of the proximal end 322 and the distal end 324of the reinforcement structure 320 can be adhered via an adhesive to theelongate member 132. In such an embodiment, the reinforcement structure320 may be uncoupled to the elongate member 132 at positions other thanthe coupling at one or both of the proximal end 322 and the distal end324 of the reinforcement structure 320, and thus the reinforcementstructure 320 is uncoupled to the elongate member 132 at a positionbetween the first end 134 and the second end 136 of the elongate member134 and/or between the proximal end 322 and the distal end 324 of thereinforcement structure 320.

The lack of coupling of the reinforcement structure 320 to the elongatemember 132 can facilitate and improve the collapse of the elongatemember 132 around a tool 400, also referred to herein as instrument 400or device 400, inserted through the valve 104 as shown in FIG. 4 . Thetool 400 can be any device inserted through the valve 104 including, forexample, one or several additional catheters, lines, wires, grippers,punches, cutters, or the like. As seen in FIG. 4 , the tool 400 isinserted through the valve 104 and specifically through the elongatemember 132 of the valve. As shown, the constricting mechanism 141 is inthe first configuration and the elongate member 132 and the centrallumen 138 of the elongate member 132 is collapsed around the tool 400,and specifically around a shaft 402 of the tool 400 to thereby seal thevalve 104 around the tool 400 and specifically around the shaft 402 ofthe tool 400. The constricting mechanism 141 can seal around tools 400that fit through the elongate member 132, regardless of the size of thetool 400. Thus, the valve can be used with a wide variety of tools.

The reinforcement structure 320 can comprise a variety of designs,shapes, sizes, and materials. In some embodiments, the reinforcementstructure 320 can be sized and shaped so as to receive elongate member132 and to be positioned between the elongate member 132 and the atleast one filament 150. In some embodiments, the reinforcement structure320 can be made from a material sufficiently strong to prevent thecutting of the at least one filament 150 through the elongate member132.

In some embodiments, the reinforcement structure can comprise a coil ora mesh sheath. The mesh sheath can, in some embodiments, comprise abraided mesh. The braided mesh can be made from any desired number ofwires in any desired configuration. In some embodiments, the braidedmesh can comprise a 4 wire braided mesh, an 8 wire braided mesh, a 12wire braided mesh, a 16 wire braided mesh, a 20 wire braided mesh, a 24wire braided mesh, a 32 wire braided mesh, a 48 wire braided mesh, a 64wire braided mesh, a 72 wire braided mesh, an 80 wire braided mesh, a 96wire braided mesh, or any other or intermediate braided mesh. In someembodiments, the braided mesh can comprise: a 1×1 configuration. In someembodiments, the wire in the braided mesh can be any desired materialincluding, for example, a metal wire such as a nitinol wire or astainless steel wire, a polymer wire, or a natural wire. In oneembodiment, the braided mesh can comprise a 48 wire mesh in a 1×1configuration made with a nitinol wire having a diameter of 0.003inches.

With reference now to FIGS. 6 through 9 , different embodiments and/orconfigurations of the filament 150 are shown. The filament 150 cancomprise a single filament 150 having a first end 600 and a second end602 as shown in FIG. 6 . The filament 150, and specifically which firstand second ends 600, 602 can be coupled to the actuator 142 to move thefilament 150 between the first and second configurations or positionsand/or from the first configuration or position to the secondconfiguration or position. In some embodiments, both of the first end600 and the second end 602 can be coupled to a single button 144, insome embodiments, each of the first end 600 and the second end 602 canbe coupled to different buttons 144, and in some embodiments, one of thefirst end 600 and the second end 602 can be coupled to a button 144 andthe other of the first end 600 and the second end 602 can be coupled tothe housing 128 or other portion of the valve 104.

In some embodiments, the filament 150 can comprise multiple filaments,and specifically, as shown in FIGS. 7 through 9 , the filament 150 cancomprise a first filament 150-A and a second filament 150-B. Inembodiments in which the filament 150 comprises multiple filaments, eachof the multiple filaments can have a first end 700 and a second end 702.The first and second filaments 150-A, 150-B can be coupled to theactuator 142. In such embodiments, the first and second ends 700, 702can be coupled to the actuator 142 to move the filaments 150-A, 150-Bbetween the first and second configurations and/or from the firstconfiguration to the second configuration. In some embodiments, both ofthe first end 700 and the second end 702 of one or more of the multiplefilaments 150 can be coupled to a single button 144, in someembodiments, each of the first end 700 and the second end 702 of one ormore of the multiple filaments 150 can be coupled to different buttons144, and in some embodiments, one of the first end 700 and the secondend 702 of one or more of the multiple filaments 150 can be coupled toone button 144 and the other of the first end 700 and the second end 702of those one or more filaments 150 can be coupled to the housing 128 orother portion of the valve 104.

The filament 150 can be arranged in a variety of configurations. In someembodiments, the filament 150 can be configured to form a single loop604 that can extend around the elongate member 132 and/or through whichthe elongate member 132 can be received as shown in FIG. 6 , and in someembodiments, the filament 150 can be configured to form multiple loops,and specifically a first loop 704 and a second loop 706 as shown in FIG.7 . The first and second loops 704, 706 can each receive the elongatemember 132. In some embodiments, a diameter or size of the loop 604, orof the loops 704, 706 can decrease when the constricting mechanism 141is moved from the second configuration to the first configuration.

In some embodiments, the filament 150 can be configured to form a bight800, which bight 800 can be a single bight or multiple bights. As usedherein, a “bight” refers to a U-shaped section between the two ends ofthe filament 150. As depicted in FIGS. 8 and 9 , the bight 800 cancomprise multiple bights, and specifically a first bight 800-A and asecond bight 800-B. In some embodiments, the first bight 800-A canextend through the second bight 800-B such that the first and secondbights 800-A, 800-B interlock, whereas in other embodiments, the firstand second bights 800-A, 800-B can be non-interlocking. Similarly, inembodiments containing the filament 150 having multiple loops, one orseveral of the multiple loops can be interlocking.

In some embodiments, the bight 800, and specifically one or both of thefirst bight 800-A and the second bight 800-B can be formed around aportion of the elongate member 132 and/or can extend around a portion ofthe elongate member 132. Each bight 800 can define a partially enclosedreceiving area 808 wherein the elongate member 132 can be received.Thus, the first bight 800-A can define a first receiving area 808-A andthe second bight 800-B can define a second receiving area 808-B.

As seen in FIGS. 8 and 9 , multiple bights, and specifically the firstand the second bights 800-A, 800-B can be positioned and oriented suchthat the first bight 800-A has a first orientation or first direction asindicated by arrow 810, and the second bight has a second orientation orsecond direction as indicated by the arrow 812. In some embodiments, thefirst orientation is different from the second orientation such that thefirst and second receiving areas 808-A, 808-B overlap and define anencircled area 814, also referred to herein as a constricting area 814.The elongate member 132 can be received within the encircled area 814.In embodiments in which bights 800-A, 800-B overlap to define theencircled area 814, the movement of the constricting mechanism 141 tothe first configuration can result in and/or include the first bight800-A moving in the direction indicated by the arrow 810 and/or thesecond bight 800-B moving in the direction indicated by the arrow 812,which movement of the bights 800-A, 800-B decreases the size of theencircled area 814 and constricts, collapses, and/or seals the elongatemember 132 extending through the encircled area 814.

The filament(s) 150 forming the bights 800 can each apply an arcuateline or narrow longitudinal zone of pressure to the elongate member 132.If the filament(s) are circular in cross-section, the zone of pressurecan be very small, and can, in some embodiments, be less than thediameter or thickness of the filament. In some embodiments, thefilaments have a diameter or width less than about 2.5 mm, less thanabout 2 mm, less than about 1.5 mm, less than about 1.25 mm, less thanabout 1 mm, less than about 0.75 mm, less than about 0.5 mm, and/or lessthan about 0.25 mm. In some embodiments, the filaments can have adiameter or width of between about 0.01 mm and 2.5 mm, between about0.05 mm and 2 mm, between about 0.1 mm and 1 mm, and/or between aboutand 0.70 mm. In some embodiments, the arcuate line or zone of pressuremay form two opposing arcs and in other embodiments, the arcuate line ofpressure may be a singular substantially circular line or zone thatencircles the elongate member at least once. The longitudinal length ofthe of the line or zone of pressure may be very short compared to othervalves known in the art. In some embodiments, the longitudinal length ofthe zone of pressure applied to the elongate member 132 by thefilament(s) 150 may be less than about 2.0 mm and in some embodimentsless than about 0.5 mm. In some embodiments, the filament(s) 150 canhave any desired cross-sectional shape including, for example, acircular cross-section, a rectangular cross-section, an ovalcross-section, a square cross-section, a polygonal cross-section, atriangular cross-section, or any other desired shape of cross-section.

With reference now to FIG. 10 , a flowchart illustrating one embodimentof a process 1000 for sealing a valve 104 and/or catheter 102 accessinga body of a patient is shown. The process 1000 can be performed usingthe valve 104 and/or the delivery system 100. The process 1000 begins atblock 1002, wherein the delivery device 100, and specifically thecatheter 102 of the delivery device 100 is inserted into the body of thepatient. In some embodiments, this can include inserting the catheter102 into a portion of the circulator system of the patient such as, forexample, a blood vessel including an artery or a venous vessel. In someembodiments, the delivery device 100 can be inserted into the body ofthe patient directly through an aperture or incision in the patient, andin some embodiments, the delivery device 100 can be inserted into thebody of the patient via another catheter or device. In some embodiments,the constricting mechanism 141 can be in the first configuration whilethe delivery device 100 and/or the catheter 102 is inserted into thepatient's body.

After the delivery device 100 is inserted into the body of the patient,the process 1000 proceeds to block 1004, wherein the constrictingmechanism 141 is moved from the first configuration to the secondconfiguration. As described above, the central lumen 138 of the elongatemember 132 is unsealed when the constricting mechanism 141 is in thesecond configuration. In some embodiments, the moving of theconstricting mechanism 141 from the first configuration to the secondconfiguration can include the manipulation of the actuator 142 and/orthe control of the actuator 142, and specifically the depressing of theone or several buttons 144 to move the filament 150 from the firstposition to the second position to allow the expansion and opening ofthe central lumen 138 of the elongate member 132.

After the constricting mechanism 141 is moved from the firstconfiguration to the second configuration, the process 1000 proceeds toblock 1006, wherein the tool 400, and specifically the shaft 402 of thetool 400 is advanced through the delivery device 100 and specificallythrough the valve 104 until a first end of the tool reaches a desiredposition within the body of the patient. In some embodiments, a portionof the shaft 402 can be positioned within the central lumen 138 of theelongate member 132 after the advancing of the tool 400 through thedelivery device 100. In some embodiments, after the tool 400 is advancedthrough the delivery device 100, the desired procedure can be performedwith the tool.

After the tool 400 is advanced through the delivery device 100, or whilethe tool 400 is being advanced through the delivery device 100, theprocess 1000 proceeds to block 1008, wherein the constricting mechanism141 is returned to the first configuration. In some embodiments, thereturning of the constricting mechanism 141 to the first configurationcan include the release of the one or several buttons 144 and/or thecontrol of the actuator 142 to reconfigure the constricting mechanism141 to the first configuration. In some embodiments, the return of theconstricting mechanism 141 to the first configuration can result in thecollapse and/or sealing of the elongate member 132 and specifically thecentral lumen 138 of the elongate member 132 around the tool 400 andspecifically around the shaft 402 of the tool 400. The return of theconstricting mechanism 141 to the first configuration, or the movementof the constricting mechanism 141 to the first configuration can includethe decreasing of the size and/or diameter of one or several loopsformed by the filament 150 and/or the movement of one or several bights800 such as, for example, the movement of the first bight 800-A in thefirst direction indicated by arrow 810 and the movement of the secondbight 800-B in the second direction indicated by arrow 812 to reduce thesize of the constricting area 814. In some embodiments, after theconstricting mechanism is returned to the first configuration, thedesired procedure can be performed with the tool.

After the constricting mechanism is returned to the first configuration,the process 1000 proceeds to block 1010, wherein the tool 400, andspecifically the shaft 402 of the tool 400 is retracted from thedelivery device 100, and more specifically from the valve 104. In someembodiments, the valve 104 can remain sealed during the retracing of thetool 400 and/or the shaft 402 of the tool. In some embodiments, thevalve 104 remains sealed during the retracting of the tool 400 and/orthe retracting of the shaft 402 of the tool 400 as the constrictingmechanism 141 can remain in the first configuration during the retracingof the tool 400 and/or the shaft 402 of the tool 400.

In some embodiments, the constricting mechanism 141 can be moved to thesecond configuration to allow the retraction of the tool 400 and/or theshaft 402 of the tool 400 from the valve 104, and the constrictingmechanism 141 can be returned to the first configuration when the tool400 and/or the shaft 402 of the tool 400 is removed from the valve 104.In some embodiments, the retraction of the tool 400 and/or shaft 402 ofthe tool 400 from the valve 104 can be performed with the constrictingmechanism 141 left in the first configuration. In some embodiments, theconstricting mechanism 141 can be moved to the second configuration, andthen returned to the first configuration via the manipulation and/orcontrol of the actuator 142, which manipulation and/or control of theactuator 142 can include the depressing of the one or several buttons144 to move the constricting mechanism 141 to the second configuration,and the release of the one or several buttons 144 to return theconstricting mechanism 141 to the first configuration. In someembodiments, if the procedure is complete, the delivery device 100 canthen be removed from the body of the patient, and any incision createdfor the procedure can be closed.

With reference now to FIG. 11 , a side view of one embodiment of athrombectomy system 1100 including the delivery device 100 and athrombus extraction device 1102 is shown. In some embodiments, thethrombectomy system 1100 can be used to access a blood vessel 1104 totreat and/or extract a thrombus 1106 from the blood vessel 1104. Thethrombus extraction device 1102 can include a self-expanding coringelement 206 and expandable cylindrical portion 208. In some embodiments,and as shown in FIG. 11 , the thrombus extraction device 1102 can be thetool 400 that can extend through the valve 104, and in some embodiments,the valve 104 can be a part of the thrombus extraction device 1102.Further details of thrombectomy systems, thrombus extraction devices,and methods of using the same are disclosed in: U.S. application Ser.No. 15/268,296, filed Sep. 16, 2016, and entitled “INTRAVASCULARTREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS, ANDMETHODS”; U.S. application Ser. No. 15/498,320, filed Apr. 26, 2017, andentitled “DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION”; and U.S.application Ser. No. 15/466,740, filed on Mar. 22, 2017, and entitled“DEVICE AND METHOD FOR TREATING VASCULAR OCCLUSION”, the entirety ofeach of which is hereby incorporated by reference herein.

With reference now to FIG. 12 , a side-section view of anotherembodiment of the hemostasis valve 104 having two piece caps 116, 120 isshown. The valve 104 can include a housing 128 defining an interiorchannel 130 through which the tubular member 132 can extend. The valve104 can include the proximal cap 116 and the distal cap 120. In someembodiments, the proximal cap 116 can comprise a two piece cap and caninclude a proximal exterior member 1200 and a proximal channel member1202. In some embodiments, the distal cap 120 can comprise a two-piececap and can include a distal exterior member 1204 and a distal channelmember 1206. In some embodiments, this coupling between the proximalexterior member 1200 and the proximal channel member 1202 and/or thecoupling between the distal exterior member 1204 and the distal channelmember 1206 can be a sealed coupling so as to prevent the leakage ofmaterial including fluid or gas between the respective ones of theproximal exterior member 1200 and the proximal channel member 1202and/or the distal exterior member 1204 and the distal channel member1206. In some embodiments, this sealing coupling can be achieved and/ormaintained via a seal such as an 1208 that can be positioned between theproximal exterior member 1200 and the proximal channel member 1202and/or between the distal exterior member 1204 and the distal channelmember 1206.

In some embodiments, the proximal exterior member 1200 can be coupled,and in some embodiments, rotatingly coupled to the proximal channelmember 1202 in a manner to allow the rotation of the proximal exteriormember 1200 without rotating the proximal channel member 1202.Similarly, in some embodiments, the distal exterior member 1204 can berotatingly coupled to the distal channel member 1206 in a manner toallow the rotation of the distal exterior member 1204 without therotating of the distal channel member 1206. In some such embodiments,the channel members 1202, 1206 can be non-rotatable with respect to thehousing 128 and/or the tubular member 132, and one or both of theexterior members 1200, 1204 can be rotatable with respect to the housing128 and/or the tubular member 132. In such an embodiment, themaintaining of the rotational position of the channel members 1202, 1206with respect to the housing 128 and/or the tubular member 132 canprevent the twisting of the tubular member 132 which can result in thesealing of the tubular member 132 regardless of the configuration of theconstructing mechanism 141.

The exterior members 1200, 1204 can comprise a variety of shapes andsizes and can include a variety of features. In some embodiments, one orboth of the exterior members 1200, 1204 can be coupled to, for example,a shaft similar to the shaft 106 shown in FIG. 1 . In some embodiments,for example, the distal exterior member 1204 can be coupled to a shaft106, including, for example, can be non-detachably coupled to the shaft106. In some embodiments, one or both of the exterior members caninclude one or several features configured to facilitate coupling withthe valve 104. These one or several features can include, for example,one or several male or female: connectors; couplers; attachmentmechanisms; or the like. In some embodiments, these one or severalfeatures can facilitate use of the valve with other existing components,instruments, tools, or the like. In some embodiments, for example, oneor both of the exterior members 1200, 1204 can comprise either a male orfemale luer fitting, and specifically as shown in FIG. 12 , the distalexterior member 1204 can comprise a male luer fitting 1210.

Several aspects of the present technology are set forth in the followingexamples.

-   -   1. A hemostatic valve for sealing a medical device, the        hemostatic valve comprising:    -   an elongate member having a first end, a second end, and a        central lumen extending therebetween, wherein the elongate        member is pliable;    -   a reinforcement structure extending along at least a portion of        the elongate member, wherein the reinforcement structure is        coupled to the elongate member; and    -   an active tensioning mechanism coupled to the elongate member,        wherein the tensioning mechanism is moveable between a first        configuration wherein the central lumen is constricted and        sealed and a second configuration wherein the central lumen is        open.    -   2. The hemostatic valve of example 1, wherein the elongate        member comprises a compliant polymer tube.    -   3. The hemostatic valve of example 1 or 2, wherein the        tensioning mechanism comprises at least one filament extending        at least partially around the elongate member.    -   4. The hemostatic valve of example 3, wherein the reinforcement        structure is positioned between the at least one filament and        the elongate member.    -   The hemostatic valve of example 4, wherein the reinforcement        structure comprises a braided mesh.    -   6. The hemostatic valve of example 4 or 5, wherein the        reinforcement structure is coupled to the elongate member at a        position proximate to the first end of the elongate member and        at a position proximate to the second end of the elongate        member.    -   7. The hemostatic valve of example 6, wherein the reinforcement        structure is not coupled to the elongate member at a position        between the first end of the elongate member and the second end        of the elongate member.    -   8. The hemostatic valve of any one of examples 3-7, wherein the        tensioning mechanism comprises an actuator coupled to the at        least one filament, wherein the actuator is moveable to control        movement of the at least one filament from a first position        wherein the central lumen is constricted and sealed to a second        position wherein the central lumen is open, wherein the at least        one filament is in the first position when the tensioning        mechanism is in the first configuration.    -   9. The hemostatic valve of example 8, wherein the actuator is        biased towards the first position.    -   10. The hemostatic valve of example 8 or 9, wherein the actuator        is biased toward the second position.    -   11. The hemostatic valve of any one of examples 8-10, wherein        the actuator comprises a manual actuator.    -   12. The hemostatic valve of any one of examples 8-11, wherein        the at least one filament forms a loop around the elongate        member.    -   13. The hemostatic valve of any one of examples 8-12, wherein        the at least one filament forms a bight around a portion of the        elongate member.    -   14. The hemostatic valve of any one of examples 8-13, wherein        the at least one filament comprises a first filament and a        second filament, wherein each of the first filament and the        second filament are coupled to the actuator, and wherein the        first filament and the second filament are moveable from the        first position to the second position.    -   15. The hemostatic valve of example 14, wherein each of the        first filament and the second filament form a loop around the        elongate member.    -   16. The hemostatic valve of example 14 or 15, wherein the first        filament forms a first bight around a first portion of the        elongate member, and wherein the second filament forms a second        bight around a second portion of the elongate member.    -   17. The hemostatic valve of example 16, wherein the first bight        extends through the second bight.    -   18. The hemostatic valve of any one of examples 1-17, further        comprising a shell defining a first aperture and a second        aperture, wherein the elongate member extends from the first        aperture to the second aperture and fluidly couples the first        aperture and the second aperture.    -   19. The hemostatic valve of any one of examples 1-18, wherein        the tensioning mechanism is self-adjustable to seal around tools        of different sizes extending through the hemostatic valve.    -   20. The hemostatic valve of any one of examples 1-19, wherein        the central lumen comprises a single lumen.    -   21. The hemostatic valve of any one of examples 1-20, wherein        the central lumen comprises a plurality of lumens.    -   22. A delivery system for intravascular access of a blood vessel        within a patient's body, the delivery system comprising:        -   a catheter having a first end, a second end, and a catheter            lumen extending therebetween;        -   a hemostatic valve coupled to the first end of the catheter,            the hemostatic valve comprising:            -   a tubular member having a first end, a second end, and a                central lumen extending therebetween, wherein the                central lumen of the tubular member is fluidly coupled                with the catheter lumen; and            -   an active tensioning mechanism coupled to the tubular                member, the tensioning mechanism moveable between a                first configuration wherein the tensioning mechanism                constricts on the central lumen and the central lumen is                sealed and a second configuration wherein the central                lumen is open.    -   23. The delivery system of example 22, wherein the hemostatic        valve further comprises a reinforcement structure extending        along at least a portion of the tubular member.    -   24. The delivery system of example 22 or 23, wherein the        reinforcement structure is located between the tensioning        mechanism and the tubular member.    -   25. The delivery system of example 24, wherein the reinforcement        structure comprises a braided mesh.    -   26. The delivery system of example 24 or 25, wherein the        reinforcement structure is coupled to the tubular member at a        position proximate to the first end of the tubular member and at        a position proximate to the second end of the tubular member.    -   27. The delivery system of example 26, wherein the reinforcement        structure is adhered to the tubular member at the first end of        the tubular member and at the second end of the tubular member.    -   28. The delivery system of example 27, wherein the reinforcement        structure is uncoupled to the tubular member between the first        end of the tubular member and the second end of the tubular        member.    -   29. The delivery system of any one of examples 22-28, wherein        the tensioning mechanism comprises at least one filament        extending at least partially around the tubular member.    -   30. The delivery system of example 29, wherein the tensioning        mechanism comprises an actuator coupled to the at least one        filament, wherein moving the tensioning mechanism from the first        configuration to the second configuration comprises moving the        actuator and the thereto coupled at least one filament from a        first position to a second position, wherein the filament        constricts and seals the central lumen of the tubular member        when the filament is in the first position.    -   31. The delivery system of example 30, wherein the actuator        comprises a manual actuator.    -   32. The delivery system of example 31, wherein the actuator        comprises a pair of opposing and depressable buttons, wherein        the buttons are biased towards an undepressed position.    -   33. The delivery system of example 31 or 32, wherein the central        lumen is sealed when the buttons are in the undepressed        position.    -   34. The delivery system of any one of examples 30-33, wherein        the filament comprises a monofilament.    -   35. The delivery system of any one of examples 30-34, wherein        the filament comprises at least one of: a polymer filament; or a        metallic filament.    -   36. The delivery system of any one of examples 22-35, wherein        the catheter comprises a thrombus extraction device.    -   37. A method of sealing a delivery device accessing a blood        vessel of a patient, the method comprising:        -   inserting the delivery device comprising a catheter and a            hemostatic valve into the blood vessel of the patient, the            catheter having a first end, a second end, and a catheter            lumen extending therethrough, and the hemostatic valve            coupled to the first end and having a tubular member            defining a central lumen fluidly coupled with the catheter            lumen and a tensioning mechanism coupled with the tubular            member, wherein the tensioning mechanism collapses and seals            the central lumen in a first configuration and thereby seals            access to the blood vessel;        -   moving the tensioning mechanism of the hemostatic valve to a            second configuration, wherein the central lumen is open and            access to the blood vessel is unsealed when the tensioning            mechanism is in the second configuration;        -   advancing a shaft of a tool through the delivery device            until a first end of the tool reaches a desired position            within the blood vessel of the patient and a portion of the            shaft is positioned within the central lumen of the tubular            member; and        -   returning the tensioning mechanism of the hemostatic valve            to the first configuration such that the tubular member            collapses on the shaft of the tool and seals around the            shaft of the tool.    -   38. The method of example 37, further comprising retracting the        shaft of the tool from the delivery device.    -   39. The method of example 38, wherein the tensioning mechanism        is maintained in the first configuration during and after the        retracting of the shaft of the tool from the delivery device.    -   40. The method of example 38 or 39, wherein the tensioning        mechanism is moved to the second configuration during the        retracting of the shaft of the tool from the delivery device,        and wherein the tensioning mechanism is returned to the first        configuration after the shaft of the tool is retracted from the        delivery device.    -   41. The method of any one of examples 37-40, wherein the        tensioning mechanism comprises at least one filament extending        at least partially around the tubular member, wherein the at        least one filament collapses the tubular member when the        tensioning mechanism is in the first configuration.    -   42. The method of example 41, wherein the at least one filament        circumferentially constricts the tubular member to collapse the        tubular member when the tensioning mechanism is in the first        configuration.    -   43. The method of example 41 or 42, wherein the hemostatic valve        comprises a reinforcement structure located between the at least        one filament and the tubular member.    -   44. The method of any one of examples 41-43, wherein the at        least one filament forms a loop around the elongate member, and        wherein moving the tensioning mechanism from the second        configuration to the first configuration reduces a size of the        loop to thereby constrict the tubular member within the loop.    -   45. The method of any one of examples 41-44, wherein the        filament forms at least one bight around a portion of the        elongate member.    -   46. The method of example 45, wherein the filament comprises a        first filament and a second filament, and wherein the at least        one bight comprises a first bight oriented in a first direction        and formed by the first filament and a second bight oriented in        a second direction and formed by the second filament, wherein        the first and second bights overlap to encircle a portion of the        tubular member within an constricting area.    -   47. The method of example 46, wherein moving the tensioning        mechanism from the second configuration to the first        configuration comprises moving the first bight in the first        direction and the second bight in the direction to reduce the        size of the constricting area and collapse and seal the central        lumen of the tubular member.    -   48. The method of any one of examples 37-47, wherein the        tensioning mechanism comprises an actuator, and wherein moving        the tensioning mechanism to the second configuration comprises        manipulating the actuator.    -   49. The method of any one of examples 37-48, further comprising        applying a vacuum to the delivery device to aspirate material        through the catheter, wherein the central lumen remains sealed        during the aspiration.    -   50. The method of any one of examples 37-49, wherein the tool        comprises a thrombus extraction device.    -   51. A hemostatic valve for sealing a medical device, the        hemostatic valve comprising:    -   an elongate member having a first end, a second end, and a        central lumen comprising a plurality of lumens extending        therebetween, wherein the elongate member is pliable; and    -   an active tensioning mechanism coupled to the elongate member,        wherein the tensioning mechanism is moveable between a first        configuration wherein the central lumen is constricted and        sealed and a second configuration wherein the central lumen is        open.

Other variations are within the spirit of the present invention. Thus,while the invention is susceptible to various modifications andalternative constructions, certain illustrated embodiments thereof areshown in the drawings and have been described above in detail. It shouldbe understood, however, that there is no intention to limit theinvention to the specific form or forms disclosed, but on the contrary,the intention is to cover all modifications, alternative constructions,and equivalents falling within the spirit and scope of the invention, asdefined in the appended claims.

In the previous description, various embodiments of the presentinvention are described. For purposes of explanation, specificconfigurations and details are set forth in order to provide a thoroughunderstanding of the embodiments. However, it will also be apparent toone skilled in the art that the present invention may be practicedwithout the specific details. Furthermore, well-known features may beomitted or simplified in order not to obscure the embodiment beingdescribed.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. The term “connected” is to beconstrued as partly or wholly contained within, attached to, or joinedtogether, even if there is something intervening. Recitation of rangesof values herein are merely intended to serve as a shorthand method ofreferring individually to each separate value falling within the range,unless otherwise indicated herein, and each separate value isincorporated into the specification as if it were individually recitedherein. All methods described herein can be performed in any suitableorder unless otherwise indicated herein or otherwise clearlycontradicted by context. The use of any and all examples, or exemplarylanguage (e.g., “such as”) provided herein, is intended merely to betterilluminate embodiments of the invention and does not pose a limitationon the scope of the invention unless otherwise claimed. No language inthe specification should be construed as indicating any non-claimedelement as essential to the practice of the invention.

Preferred embodiments of this invention are described herein, includingthe best mode known to the inventors for carrying out the invention.Variations of those preferred embodiments may become apparent to thoseof ordinary skill in the art upon reading the foregoing description. Theinventors expect skilled artisans to employ such variations asappropriate, and the inventors intend for the invention to be practicedotherwise than as specifically described herein. Accordingly, thisinvention includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein.

What is claimed is:
 1. A valve, comprising: an elongate member defininga lumen; an active tensioning mechanism including an actuator coupled tothe elongate member via a filament extending at least partially aroundthe elongate member, wherein the actuator is moveable between (a) afirst position wherein the lumen is constricted and sealed and (b) asecond position wherein the lumen is at least partially open; and abiasing member configured to bias the actuator to the first position. 2.The valve of claim 1 wherein the elongate member is pliable.
 3. Thevalve of claim 1 wherein the filament extends in a loop around theelongate member.
 4. The valve of claim 1 wherein the actuator is abutton, wherein the button is undepressed in the first position, andwherein the button is depressed in the second position.
 5. The valve ofclaim 1 wherein, when the actuator is in the first position, the lumenis configured to remain constricted and sealed when a pressuredifferential exists between (a) a first volume outside the lumen andadjacent to a first end of the elongate member and (b) a second volumeoutside the lumen and adjacent to a second end of the elongate member.6. The valve of claim 1 wherein, when the actuator is in the firstposition, the lumen is configured to remain constricted and sealed whenvacuum pressure is applied to a volume outside the lumen and adjacent toeither a first end or a second end of the elongate member.
 7. The valveof claim 1 wherein the lumen extends a long a first longitudinal axis,wherein the actuator is movable between the first and second positionsalong a second longitudinal axis, and wherein the first longitudinalaxis is orthogonal to the second longitudinal axis.
 8. The valve ofclaim 1 wherein the biasing member is a compression spring.
 9. The valveof claim 1 wherein, in the first position, the actuator pulls thefilament to circumferentially constrict the elongate member such thatthe lumen is constricted and sealed.
 10. The valve of claim 1 whereinthe actuator is a first actuator, wherein the filament is a firstfilament, wherein the biasing member is a first biasing member, andwherein the active tensioning mechanism further comprises: a secondactuator coupled to the elongate member via a second filament extendingat least partially around the elongate member, wherein the secondactuator is moveable between (a) a first position wherein the lumen isconstricted and sealed and (b) a second position wherein the lumen is atleast partially open; and a second biasing member configured to bias thesecond actuator to the first position.
 11. The valve of claim 10 whereinthe first filament has a first end portion coupled to the first actuatorand a second end portion coupled to the first actuator, and wherein thesecond filament has a first end portion coupled to the second actuatorand a second end portion coupled to the second actuator.
 12. The valveof claim 11 wherein the first filament and the second filament at leastpartially overlap to define a constricting region about the elongatemember.
 13. The valve of claim 12 wherein, when the second actuator ismoved to the second position and/or the second actuator is moved to thesecond position, a size of the constricting region increases.
 14. Thevalve of claim 10 wherein the first filament extends in a loop aroundthe elongate member, and wherein the second filament extends through theloop of the first filament around the elongate member.
 15. A valve,comprising: an elongate member defining a lumen; a filament coupled tothe elongate member; an actuator coupled to the filament, wherein theactuator is moveable between (a) a first position wherein the lumen isconstricted and sealed and (b) a second position wherein the lumen is atleast partially open; and a biasing member configured to bias theactuator to the first position.
 16. The valve of claim 15 wherein thefilament extends at least partially around the elongate member.
 17. Thevalve of claim 16 wherein, in the first position, the actuator pulls thefilament to circumferentially constrict the elongate member such thatthe lumen is constricted and sealed.
 18. The valve of claim 15 whereinthe elongate member is pliable.
 19. The valve of claim 15 wherein thefilament is monofilament.
 20. The valve of claim 15 wherein the actuatoris a button that is undepressed in the first position and depressed inthe second position, wherein the button is movable between the first andsecond positions along a first longitudinal axis, wherein the lumenextends a long a second longitudinal axis, and wherein the firstlongitudinal axis is orthogonal to the second longitudinal axis.
 21. Avalve, comprising: an elongate member defining a lumen; a filamentcoupled to the elongate member; and an actuator coupled to the elongatemember, wherein the actuator is moveable between (a) a first position inwhich the actuator pulls the filament to collapse the elongate membersuch that the lumen is constricted and sealed and (b) a second positionwherein the lumen is at least partially open; a biasing memberconfigured to bias the actuator to the first position.
 22. The valve ofclaim 21 wherein the elongate member is pliable, and wherein thefilament extends at least partially around the elongate member.
 23. Thevalve of claim 21 wherein the elongate member is pliable, and whereinthe filament is looped around the elongate member.
 24. The valve ofclaim 21 wherein the actuator does not substantially pull the filamentin the second position such that the elongate member can expand.
 25. Avalve, comprising: an elongate member defining a lumen; and an activetensioning mechanism including a first actuator coupled to the elongatemember via a first filament and a second actuator coupled to theelongate member via a second filament, wherein the first filament andthe second filament at least partially overlap to define a constrictingregion, wherein the elongate member extends through the constrictingregion, and wherein the first actuator and/or the second actuator ismoveable between (a) a first position in which the constricting regionhas a decreased size such that the lumen is constricted and sealed and(b) a second position in which the constricting region has an increasedsize such that the lumen is at least partially open.
 26. The valve ofclaim 25, further comprising at least one biasing member configured tobias the first actuator and/or the second actuator to the firstposition.